A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 2, 2023

Primary Completion Date

May 13, 2025

Study Completion Date

January 31, 2026

Conditions
Primary Membranous Nephropathy
Interventions
DRUG

MIL62

An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at Week 1 and Week 3.If the treatment is effective, MIL62 will continue be administered at W25 and W27

DRUG

Cyclosporine

Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d in 2 divided doses, try to give every 12 hours.The dose was adjusted according to the blood concentration of cyclosporine monitored every 2 weeks±3 days until the target blood concentration of 125\~175 ng/mL was reached.Optimized cyclosporine dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks.

Trial Locations (1)

Unknown

Peking University First Hospital, Beijing

All Listed Sponsors
lead

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY